FDA Inspection
Rebgro CorporationRebgro Corporation – FDA Inspection, Jan 15, 2010
Record Details
This FDA Inspection record concerns Rebgro Corporation, with an inspection on January 15, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Rebgro Corporation
- Inspection Date
- January 15, 2010
- Product Type
- Drugs
View Company Profile
ID · e5bf782c-3a86-454a-8908-1e1094936a3d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 638576
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rebgro Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Rebgro Corporation
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.